Professional Documents
Culture Documents
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Designation: E 1965 – 98
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
1
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
Contact¬ASTM¬International¬(www.astm.org)¬for¬the¬latest¬information.¬
E 1965
3.2.5 blackbody temperature [tBB], n—temperature of 3.2.21 instrumentational offset [µd], n—calculated differ-
blackbody cavity walls as measured by an imbedded or ence in degrees of measured temperature between core tem-
immersed contact thermometer. perature and ear canal temperature, derived from the popula-
3.2.6 bladder temperature, n—temperature of the interior of tion of representative study samples.
urinary bladder as measured by a contact thermometer. 3.2.22 internal, adj—of the interior of subject’s body or
3.2.7 body temperature, n—temperature measured from the body cavity, such as pulmonary artery, urinary bladder, oral,
interior of a human body cavity, such as pulmonary artery, rectal, etc.
distal esophagus, urinary bladder, ear canal, oral, or rectal. 3.2.23 laboratory error [d], n—difference between unad-
3.2.8 clinical accuracy, n—ability of an infrared ear canal justed temperature as measured by an IR thermometer and
thermometer to give a reading close to true temperature of the temperature of a blackbody, over specified operating condi-
site that it purports to represent. tions of ambient temperature and humidity and blackbody
3.2.9 clinical bias [x̄d], n—mean difference between IR temperature ranges.
thermometer output and an internal body site temperature from 3.2.24 operating temperature, n—ambient temperature that
subjects at specified conditions of ambient temperature and allows operation of an IR thermometer within specified labo-
humidity and averaged over a selected group of subjects. ratory error range.
3.2.10 clinical repeatability [sr], n—pooled standard devia- 3.2.25 operating humidity, n—relative humidity of ambient
tion of changes in multiple ear canal temperature readings as air which allows operation of an IR thermometer within a
taken from the same subject from the same ear with the same specified laboratory error range.
infrared thermometer by the same operator within a relatively 3.2.26 oral temperature [tbm], n—posterior sublingual tem-
short time. perature as measured by a contact thermometer.
3.2.11 combined site offset [µs], n—calculated difference in 3.2.27 physiological site offset, [µp], n—difference in de-
degrees of measured temperature between a selected reference grees of measured temperature between two body sites derived
body site and ear canal temperature and averaged over the from the representative study samples.
population of representative study samples. 3.2.28 probe, n—part of an IR thermometer that channels
3.2.12 contact thermometer, n—an instrument that is net infrared radiation between the subject and the sensor and is
adapted for measuring temperature by means of thermal intended to be positioned near or inside the subject.
conductivity by determining temperature at the moment when 3.2.29 probe cover, n—disposable or reusable sanitary bar-
negligible thermal energy flows between the thermometer and rier enveloping that part of the probe which otherwise would
the object of measurement. come in contact with a subject.
3.2.13 core temperature [tc], n—temperature at a subject’s 3.2.30 professional use, n—intended or implied use of an
body site, such as pulmonary artery, distal esophagus, urinary instrument by individuals that are licensed or certified for
bladder, or tympanic membrane, recognized as indicative of collecting information for medical diagnosing purposes.
internal body temperature and obtained with a contact ther- 3.2.31 rectal temperature [tbr], n—temperature in the anal
mometer. canal as measured by a contact thermometer.
3.2.32 resolution, n—minimum temperature increment dis-
3.2.14 mode, n—an output of an IR thermometer that gives
played by an IR thermometer in degrees Celsius or Fahrenheit.
a representation of a temperature using a disclosed calculation
3.2.33 scale, n—graduation of temperature display in de-
technique with respect to selected reference (for example,
grees Celsius or Fahrenheit.
blackbody, oral, rectal, etc.).
3.2.34 sensor, n—device designed to respond to net IR
3.2.15 displayed temperature range, n—temperature range
radiation and convert that response into electrical signals.
in degrees Celsius or Fahrenheit that can be shown by an IR
3.2.35 skin temperature, n—average temperature of a flat
thermometer.
skin surface as measured from the field of view of an IR skin
3.2.16 IR thermometer type, n—an optoelectronic instru- type thermometer, with an appropriate adjustments for skin
ment that is capable of noncontact infrared temperature mea- emissivity.
surement when placed into the auditory canal of a subject (ear 3.2.36 system, n—combination of an IR thermometer and an
canal type) or from the subject’s body surface (skin type). installed probe cover.
3.2.17 ear canal temperature [tec], n—displayed unadjusted 3.2.37 subject, n—a human whose temperature is measured.
temperature measured from the field of view of an IR thermom- 3.2.38 true temperature, n—temperature attributed to a
eter whose probe is placed into the auditory canal of a subject particular site of a subject or object of measurement and
according to the manufacturer’s recommendations. accepted as having a specified uncertainty.
3.2.18 field of view, n—area of a subject’s surface that 3.2.39 tympanic temperature [tty], n—temperature of either
exchanges thermal radiation with the sensor. tympanic membrane as measured by a contact thermometer.
3.2.19 infrared (IR), adj—of the electromagnetic radiation 3.2.40 unadjusted mode, n—an output of IR thermometer
within the mid- and far infrared spectral ranges (approximately that displays temperature measured and calculated from a
from 3 to 30 µm wavelength). subject or object, without any corrections for variations in
3.2.20 infrared (IR) thermometer, n—optoelectronic instru- operating temperature, subject temperature, emissivity, etc.
ment adapted for noncontact measurement of temperature of a
subject by utilizing infrared radiation exchange between the 4. Classification
subject and the sensor. 4.1 IR thermometers may be classified into two types: “ear
2
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
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E 1965
canal IR thermometers” and “skin IR thermometers.” 5.6.1.3 Under no circumstances may the upper limit of
4.1.1 The ear canal IR thermometer is intended for assessing operating temperature range be less than 35 °C (95 °F).
the internal temperature of a subject. 5.6.2 Operating Humidity Range—The relative humidity
4.1.2 The skin IR thermometer is intended for assessing the range for the operating temperature range as specified in 5.6.1
outer surface temperature of a subject. is up to 95 %, noncondensing.
5.6.3 Shock:
5. Requirements
5.6.3.1 The instrument with batteries installed (if appli-
5.1 The following requirements shall apply to any IR cable) without a carrying (storage) casing shall withstand drops
thermometer that is labeled to meet these specifications. with controlled orientation of the device without degradation of
5.2 Displayed Temperature Range: accuracy as specified in 5.3 or 5.4, or both, for a blackbody
5.2.1 In any display mode, an ear canal IR thermometer temperature of or near 37 °C (98.6 °F), when tested according
shall display a subject’s temperature over a minimum range of to 6.3.
34.4 to 42.2 °C (94.0 to 108.0 °F). 5.6.3.2 If an IR thermometer does not meet requirement of
5.2.2 A skin IR thermometer shall display a subject’s 5.6.3.1, a means of detecting and informing the user of its
temperature over a minimum range of 22 to 40.0 °C (71.6 to inoperable state, after being subjected to shock, shall be
104.0 °F). provided.
5.3 Maximum Permissible Laboratory Error (for an Ear 5.6.4 Storage Conditions—The instrument shall meet the
Canal IR Thermometer): accuracy requirements of 5.3 or 5.4, or both, after having been
5.3.1 Within the manufacturer’s specified operating ambient stored or transported, or both, at any point in an environment
conditions (see 5.6), laboratory error d as measured according of – 20 to + 50 °C (– 4 to + 122 °F) and relative humidity up
to 6.1.4 shall be no greater than values specified below: to 95 %, noncondensing, for a period of one month. The test
5.3.1.1 For blackbody temperature range from 36 to 39 °C procedure is specified in 6.1.6.
(96.8 to 102.2 °F) 5.6.5 Cleaning and Disinfection—Instrument performance
0.2 °C (0.4 °F). shall not be degraded by using the manufacturer’s recom-
5.3.1.2 For blackbody temperatures less than 36 °C (96.8 mended procedures for cleaning and disinfection provided in
°F) or greater than 39 °C (102.2 °F) the instruction manual. Such procedures are part of the
0.3 °C (0.5 °F). required documentation in 7.2.2.
5.4 Maximum Permissible Laboratory Error (for a Skin IR
5.6.6 Electromagnetic Immunity—An IR thermometer that
Thermometer):
is intended for professional use shall meet the accuracy
5.4.1 Within the manufacturer’s specified operating ambient
requirements of 5.3 or 5.4, or both, for temperature ranges of
conditions (see 5.6) over the display temperature range as
6.3.2, during and after exposure to electromagnetic interfer-
specified in 5.2.2, laboratory error d as measured according to
ence.
6.1.5 shall be no greater than 0.3 °C (0.5 °F).
5.6.7 Electrostatic Discharge—An IR thermometer shall
5.5 Special Requirements:
meet the accuracy requirements of 5.3 and 5.4, or both, for
5.5.1 Clinical Accuracy:
temperature ranges of 6.3.2, after 5 s from being subjected to
5.5.1.1 The clinical accuracy requirement is applicable only
electrostatic discharge.
to an ear canal IR thermometer system and the corresponding
age groups of subjects for which such thermometer is labeled 5.7 Low Power Supply Operation—The instrument shall
or implied to be used. operate at power supply voltage lower by no less than 0.1 V
5.5.1.2 Clinical accuracy shall be determined separately for than that required for indication of low power supply sign as
each of the following conditions: for each device model, for specified by 5.8.3. The test of operation is defined in 6.3.2 and
each adjusted display mode, and for every age group of febrile 6.3.3.
and afebrile subjects on which the IR thermometer is intended 5.8 Display and Human Interface:
to be used. 5.8.1 Resolution—The resolution of a display shall be 0.1
5.5.1.3 Any disclosure of clinical accuracy claims shall be °C (0.1 °F).
accompanied by disclosure of methodology and procedures. 5.8.2 Modes:
Such information shall be made available on request. 5.8.2.1 An IR thermometer shall indicate in what mode the
5.5.1.4 Clinical accuracy should be determined in form of instrument is set.
two characteristics—clinical bias with stated uncertainty and 5.8.2.2 Unadjusted Mode—The unadjusted mode shall be
clinical repeatability, as defined in 3.2.8. accessible by the user either by setting the instrument into that
5.6 Ambient Conditions: mode directly or by a conversion technique from adjusted
5.6.1 Operating Temperature Range: mode.
5.6.1.1 The system shall meet laboratory error requirements 5.8.2.3 Adjusted mode sets an IR thermometer to represent
as specified in 5.3 or 5.4, or both, when operating in an a reference body site, such as core, oral, rectal, etc.
environment from 16 to 40 °C (60.8 to 104.0 °F). 5.8.3 Warning Signs—The instrument shall have means to
5.6.1.2 If the operating temperature range is narrower than inform the operator when the following are outside the
specified in 5.6.1.1, the device shall be clearly labeled with a operating ranges specified by the manufacturer: power supply,
cautionary statement of the maximum or minimum operating subject temperature, and ambient temperature.
temperatures, or both. 5.9 Construction:
3
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
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E 1965
5.9.1 Housing Materials—All materials that may come in 6.1.1.1 Laboratory Accuracy Tests:
contact with the operator or a subject shall be nontoxic. 6.1.1.2 General—Laboratory accuracy tests are intended for
5.9.2 Probe Covers: verifying compliance of the design and construction of a
5.9.2.1 To provide a sanitary barrier between a subject and particular type or model of IR thermometer with the error
the probe, a probe cover that comes in contact with a subject, limitations specified in 5.3 or 5.4, or both.
if such a probe cover is required by the manufacturer, shall
6.1.2 Laboratory accuracy of an IR thermometer shall be
maintain its physical integrity while being placed on the probe
tested in all available display modes.
and during temperature measurement.
5.9.2.2 A probe and a probe cover of the system shall have 6.1.3 Blackbody:
shape and dimensions that prevent injury to a subject of any 6.1.3.1 Under laboratory conditions, an IR thermometer
age. shall be tested against a blackbody standard. A recommended
5.9.2.3 A probe cover shall not increase laboratory errors blackbody design is provided in Annex A1. The temperature of
whose limits are set in 5.3.1. a blackbody shall be measured by the IR thermometer being
5.10 Labeling and Marking (Instruments and Accessories): tested in accordance with a procedure recommended by the
5.10.1 Thermometer and Accessories: manufacturer for the particular IR thermometer.
5.10.1.1 A thermometer shall clearly indicate the units of its 6.1.3.2 The true temperature of the blackbody shall be
temperature scale. monitored by a contact imbedded or immersed thermometer
5.10.1.2 An IR thermometer housing shall be clearly with uncertainty no greater than 6 0.03 °C (6 0.05 °F).
marked with the trade name or type of the device, or both, 6.1.3.3 A manufacturer may require that an IR thermometer
model designation, name of the manufacturer or distributor,
is tested only with a manufacturer specified blackbody, rather
and lot number or serial number.
than that described in Annex A1.
5.10.1.3 An IR thermometer intended for professional use
shall be conspicuously labeled with indication of the unad- 6.1.4 Ear Canal Type IR Thermometer:
justed or adjusted mode(s), or both, that correspond to the 6.1.4.1 Tests shall be repeated for three blackbody tempera-
temperature value(s) capable of being displayed by the instru- tures, tBB set within 6 0.5 °C (6 1 °F) from the following
ment. Such labeling is optional for IR thermometers that temperatures: 35, 37, and 41 °C, (95, 98.6, and 105.8 °F). At
display only one mode and are intended for non-professional each blackbody temperature, the tests shall be repeated under
use. However, as required in 7.2.1.3, the instruction manual for the ambient conditions stated in Table 1.
both professional and non-professional use IR thermometers
NOTE 4—For an IR thermometer that is specified for a different
shall specify the body site(s) (that is, oral, rectal, core) used to operating temperature range than that required in 5.6.1.1, temperatures in
reference the adjusted temperature value(s) displayed. Table 1 marked with an asterisk shall be changed for the respective limits
NOTE 3—All markings shall not deteriorate after prolonged use or of such specified operating temperature range.
cleaning.
6.1.4.2 Prior to the measurements, the IR thermometer shall
5.10.2 Probe Covers Package: be stabilized at given conditions of ambient temperature and
5.10.2.1 The package shall state the name and type of the humidity for a minimum of 30 min or longer if so specified by
enclosed products, name of the manufacturer or distributor, lot the manufacturer.
number or serial number, and expiration date (if the probe 6.1.4.3 At each combination of operating temperature and
covers have limited shelf life). humidity in Table 1, at least six measurements shall be taken
5.10.2.2 The thermometer model(s) for which the covers are for each blackbody temperature, tBB. The number of readings
intended for use shall be specified on the probe cover package. shall be the same for all combinations. A new disposable probe
5.10.2.3 The package shall state whether the probe cover is cover (if applicable) must be used for each test reading. The
intended for single use or multiple use. rate and method of temperature taking shall be in compliance
5.10.2.4 Any probe cover handling, application, storage, or with the manufacturer’s recommendations.
cleaning procedures which impact the ability of an IR ther-
mometer to meet the requirements for maximum permissible 6.1.4.4 The requirements of 5.3 demand that no individual
laboratory error specified in 5.3 shall be stated. error dj exceeds the specified limits for laboratory error. The
individual measurement error is:
6. Test Methods dj 5 ?tj – tBB? (1)
6.1 The tests are not required for every produced instru-
ment. However, each producer or distributor who represents its
instruments as conforming to this specification shall utilize TABLE 1 Conditions of Ambient Temperature and Humidity for
Testing an IR Thermometer with a Blackbody for Each of Three
statistically based sampling plans that are appropriate for each Blackbody Settings
particular manufacturing process, in the design qualification of
Operating Temperature Relative Humidity (%)
the device, and shall keep such essential records as are
16 to 18 °C (60 to 65 °F)* less than 50
necessary to document with a high degree of ensurance its 16 to 18 °C (60 to 65 °F)* 90 to 95
claims that all of the requirements of this specification are met. 24 to 26 °C (75 to 80 °F) 40 to 60
6.1.1 The manufacturer shall make the sampling plans 38 to 40 °C (100 to 104 °F)* less than 25
38 to 40 °C (100 to 104 °F) 75 to 85
available upon request.
4
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
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E 1965
(concrete block). The test shall be performed with a controlled
tj 5 displayed or calculated value of unadjusted tem- orientation of the device once for each of two axes (see Fig. 1)
perature, where the IR thermometer probe faces down. Axis A is defined
tBB 5 true temperature of the blackbody, as an optical axis of the probe. Axis B passes through the IR
j 5 sequential number of a reading, thermometer center of gravity and the point where the window
{ 5 signifies taking an absolute value. of the probe crosses axis A.
6.1.4.5 In each mode, three data sets shall be formed. Each NOTE 5—If axes as in Fig. 1 cannot be identified for a particular
data set is comprised of values dj obtained at the same thermometer, the drop direction shall be that which may cause the greatest
blackbody temperature setting by pooling together values for damage.
all combinations of operating temperature and humidities
6.3.2 The IR thermometer’s operation shall be tested by
obtained at that blackbody temperature. The largest dj is a
measuring the temperature of a blackbody that is set within 6
measure of the laboratory error of a system.
0.5 °C (6 1 °F) from 37 °C (98.6 °F), at ambient temperature
6.1.4.6 The correction method to arrive at unadjusted tem- in the range from 20 to 26 °C (68 to 79 °F) and relative
perature tj from readings in adjusted mode(s) shall be used humidity in the range from 40 to 70 %. A total of at least five
according to the manufacturer’s recommendation. Such recom- measurements shall be performed by using a new disposable
mendations shall be available from the manufacturer on request probe cover (if applicable) for every measurement. The IR
and provided in the service and repair manual, if any (see 7.3). thermometer shall be set in an unadjusted mode as specified in
6.1.4.7 To comply with this standard, the greatest calculated 5.8.2.2.
error dj from all data sets measured and calculated for all 6.3.3 The unadjusted temperature value shall be subtracted
display modes shall conform with requirements set forth in 5.3. from the blackbody setting. The absolute value of the largest
6.1.5 Skin Type IR Thermometer: error shall be no greater than the error limit set forth in 5.3 (or
6.1.5.1 Testing is as specified in 6.1.4 except that blackbody 5.4, whichever is applicable) for the blackbody temperature
temperatures shall be set within 6 1°C (6 2 °F) from the range from 36 to 39 °C (96.8 to 102.2 °F).
following temperatures: 23, 30, and 38 °C (73, 86, and 100 °F) 6.4 Electromagnetic Susceptibility Test:
6.1.5.2 The greatest calculated error dj from all data sets 6.4.1 The instrument under test shall be exposed to a
shall conform with requirements set forth in 5.4. modulated electromagnetic radiofrequency field with the fol-
6.1.6 Storage Test—To test compliance with storage condi- lowing characteristics and in accordance with standards
tions, an IR thermometer shall be maintained in an environ- IEC601-1-2 and IEC 1000-4-3.
mental chamber at temperature –20 °C (–4 °F), relative 6.4.1.1 Field Strength—3 V/m;
humidity below 50 %, for a period of 30 days and at 50 °C (122 6.4.1.2 Carrier Frequency Range—26 MHz to 1 GHz;
°F), relative humidity no less than 75 % noncondensing, for a 6.4.1.3 Frequency Sweep Interval: 1 MHz/s, minimum;
period of 30 days. After each exposure the IR thermometer 6.4.1.4 Frequency Interval Dwell Time: The larger of either
shall be tested according to 6.3.2 and 6.3.3.
6.2 Clinical Accuracy Tests—This specification does not
prescribe an actual method for determining clinical accuracy or
establish specifications for values which characterize clinical
accuracy. Manufacturers shall perform clinical accuracy testing
in accordance with methods acceptable to the U.S. Food and
Drug Administration. An example of a method which may be
used for this purpose is provided in X2.3.
6.2.1 Purpose of Tests—Clinical accuracy tests are intended
for evaluation of accuracy of built-in instrumentational or
combined site offsets, or both, and performance of an IR
thermometer in assessing internal body temperatures from
actual subjects. While this specification does not set limits for
clinical accuracy, it is the responsibility of a manufacturer to
determine values characterizing clinical accuracy and disclose
them upon request.
6.2.2 Reference Sites—The tests shall be performed on
groups of subjects by using an internal body site (for example,
pulmonary artery or sublingual cavity) for the reference
measurements. During clinical tests, the IR thermometer under
test shall be set in the corresponding mode.
6.3 Shock Test:
6.3.1 To test the ability of an IR thermometer to comply
with 5.6.3, it shall be subjected to a fall from a height of 1 m NOTE 1—IR thermometer is shown in the fall position along Axis B.
(39 in.) onto a 50 mm (2 in.) thick hardwood board (hardwood FIG. 1 Axes of IR Thermometer Defined for the Purpose of Shock
of density higher than 700 kg/m3) that lies flat on a rigid base Test
5
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
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E 1965
1 s. or the measurement response time of the instrument under be tested according to the procedures of 6.3.2 and 6.3.3.
test;
6.4.1.5 AM modulation, 80 % index with a sine wave or 7. Documentation
100 % with a square wave having a 50 % duty cycle. A 7.1 Identification:
modulation frequency that is within each significant signal- 7.1.1 In order that purchasers may identify products con-
processing passband of the instrument under test shall be used. forming to requirements of this specification, producers and
For devices not having a defined passband, modulation shall be distributors may include a statement of compliance in conjunc-
1 Hz, 10 Hz, and 1 kHz. tion with their name and address on product labels or associ-
6.4.2 Specific conditions for testing are as follows: ated printed materials, or both, such as invoices, sales litera-
6.4.2.1 No change of the probe covers is required while ture, and the like. The following statement is suggested: “This
performing the electromagnetic compatibility test. infrared thermometer meets requirements established in ASTM
6.4.2.2 The IR thermometer probe shall be aimed at a target Standard (E 1965-98). Full responsibility for the conformance
whose surface temperature is within the display range of the IR of this product to the standard is assumed by (name and
thermometer. The target does not have to be a blackbody. address of producer or distributor).” In the event one or more
6.4.2.3 IR thermometers capable of producing continuous provisions of this standard are not met, a cautionary statement
temperature readings shall have their readings taken succes- shall be included.
sively and compared to one another during the frequency 7.1.2 The IR thermometer shall be identified as intended for
sweep interval. professional or consumer use, or both, as applicable.
6.4.2.4 IR thermometers not capable of producing continu- 7.2 Instruction Manual:
ous temperature readings shall have their circuitry modified to 7.2.1 Specifications—An instruction manual shall be pro-
allow for continuous monitoring of the IR and reference vided and contain the system specifications, including but not
temperature signals. The peak excursions of the monitored IR limited to the following:
and reference temperature signals measured during frequency 7.2.1.1 Displayed temperature range.
sweep interval shall be recalculated to represent the corre- 7.2.1.2 Maximum laboratory error.
sponding temperature excursions. On request, the manufacturer 7.2.1.3 Body site(s) used as a reference for adjusting the
shall make available the method of the circuit modification. displayed temperature value.
6.4.2.5 IR thermometers having digital output shall have 7.2.1.4 Applicable subject categories for each display mode.
their signal monitored at the output of the analog-to-digital 7.2.1.5 Required period of recalibration or reverification, if
converter. applicable.
7.2.1.6 Environmental characteristics (operating and storage
NOTE 6—Modification of the circuit should not affect dimensions of the
ranges for temperature and humidity).
circuit board or significantly alter position of components and conductors.
7.2.1.7 Statement informing that clinical accuracy charac-
6.4.2.6 Non-conductive and dielectric connections (for ex- teristics and procedures are available from the manufacturer on
ample, fiber-optic) shall be used between the IR thermometer request.
and all test equipment so as to minimize perturbations of the 7.2.2 Detailed instructions—The instruction manual shall
electromagnetic field. contain adequate instructions for use with sufficient detail for
6.4.2.7 Calculated temperature excursions shall deviate training in the operation, application, care, and biological and
from one another by value no greater than required by 5.6.6. physical cleaning of the instrument and accessories. The
6.5 Electrostatic Discharge Tests: instruction manual shall include warnings if performance of the
6.5.1 The effects of electrostatic discharge on accuracy of an instrument may be adversely affected should one or more of the
IR thermometer shall be tested in compliance with provisions following occur:
of standard IEC 1000-4-2: 1995. Specific conditions for testing 7.2.2.1 Operation outside of the manufacturer specified
are as follows: subject temperature range.
6.5.1.1 The IR thermometer shall be in a “power on” state 7.2.2.2 Operation outside of the manufacturer specified
when subjected to electrostatic discharge. operating temperature and humidity ranges.
6.5.1.2 Ten air and ten contact discharges shall be applied. 7.2.2.3 Storage outside of the manufacturer specified ambi-
6.5.1.3 If IR thermometer under test has no exposed elec- ent temperature and humidity ranges.
trically conductive parts, only air discharge shall be applied. 7.2.2.4 Mechanical shock.
6.5.2 Air Discharge: 7.2.2.5 Manufacturer defined soiled or damaged infrared
6.5.2.1 The discharge shall be aimed at an electrically optical components.
nonconductive part of the IR thermometer probe with no probe 7.2.2.6 Absent, defective, or soiled probe cover (if appli-
cover attached. cable).
6.5.2.2 The level of discharge shall be 2, 4, and 8 kV. 7.2.2.7 Use of unspecified probe covers.
6.5.3 Contact Discharge: 7.2.3 Blackbody—The instruction manual shall indicate the
6.5.3.1 The probe of the electrostatic discharge device shall type and availability of a blackbody recommended for verify-
touch one of the electrically conductive parts on the outside of ing laboratory or clinical accuracy, or both, if only such type is
the IR thermometer housing. required by the manufacturer as addressed in 6.1.3.3.
6.5.3.2 The level of discharge shall be 2, 4, and 6 kV. 7.2.4 The instruction manual shall specify whether the
6.5.4 After electrostatic discharge, the IR thermometer shall probe cover is intended for single use or multiple use. If
6
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
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E 1965
multiple use is allowed, cleaning instructions and criteria for 7.3 Service and Repair Manual:
determining when a probe cover should be discarded shall be 7.3.1 A detailed service manual shall be made available if
specified. Cleaning instructions shall be adequate to prevent user service or repair is permitted by the manufacturer.
cross-contamination between patients. 7.3.2 A service manual shall disclose values of instrumen-
7.2.5 The instruction manual shall inform the user of tation or combined site offsets, or both.
differences in the accuracy of measurements obtained with IR 7.3.3 A service manual shall provide a method of arriving to
thermometers versus contact thermometers (that is, mercury- unadjusted readings from temperatures displayed in an ad-
in-glass and electronic thermometers). Such differences shall justed mode.
include, whenever applicable, a description of the anticipated 7.4 Accuracy Determination—A manufacturer shall make
error sources associated with disposable or reusable probe available upon request specific instructions for tests to deter-
covers and sleeves, operators’ technique, anatomical varia- mine the laboratory error, clinical bias and clinical repeatability
tions, earwax buildups, subject cooperation, etc. In addition, of an IR thermometer. When describing how clinical tests are
this section of the instruction manual that explains differences performed, the manufacturer shall disclose the profile of
in the accuracy of measurements obtained with IR thermom- subject groups tested, including age and febrile status. A
eters versus contact thermometers shall conspicuously include detailed procedure for taking reference temperatures also shall
the following statement: “ASTM laboratory accuracy require- be disclosed.
ments in the display range of 37 to 39 °C (98 to 102 °F) for IR
thermometers is 6 0.2 °C (6 0.4 °F), whereas for mercury- 8. Keywords
in-glass and electronic thermometers, the requirement per 8.1 auditory canal; body temperature; ear; fever; infrared;
ASTM Standards E 667-86 and E 1112-86 is 6 0.1 °C (6 0.2 medical instrument; temperature; thermometer; tympanic
°F).” membrane
ANNEX
(Mandatory Information)
6
The boldface numbers given in parentheses refer to a list of references at the must have a diameter sufficiently small for the snug fitting of
end of the text. the probe with a probe cover attached (if applicable). The probe
7
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
Contact¬ASTM¬International¬(www.astm.org)¬for¬the¬latest¬information.¬
E 1965
end preferably should be aligned with the rim of the opening True temperature of the water shall be monitored with an
and should not protrude into the cavity by more than 2 m (0.08 uncertainty no greater than 6 0.03 °C (0.05 °F) by an
in.). No metal portion of the cavity should be positioned above immersed contact thermometer for which the calibration is
the water level. The shape and dimensions of the opening into traceable to a national physical standard of temperature. The
the blackbody shall correspond to those specified by the contact thermometer should be positioned into the water in
manufacturer of the instrument being tested. The opening shall close proximity to the blackbody cavity.
ensure that the probe is properly positioned in the blackbody
when manually inserted. A1.4 It is possible for the test purposes to use a blackbody
of a different design. However, emissivity of such a blackbody
A1.3 The water bath shall have a volume of 2 L (2 qt) or shall be known in comparison to the one described above, and
greater and temperature stability within 6 0.02 °C (0.04 °F). used for correction in measured temperatures.
APPENDIXES
(Nonmandatory Information)
X1. BACKGROUND
E 1965
Tb 5 Œ
4 Fb
T 4s 1 Ase e
b s
(X1.2)
laboratory error measured according to 6.1 will appear too
high.
where: Tb represents the calculated temperature. X1.3.6.4 Therefore, in reality all “blackbodies” do not have
X1.3.4 The calculation requires an accurate detection of two the same emissivity. When an IR thermometer’s laboratory
independent variables, the surface temperature Ts of the sensor accuracy is verified according to 6.1 using a blackbody whose
(or reference target) and the net infrared flux Fb between the emissivity (eb) is different than that of the blackbody originally
sensor and subject. used to calibrate the device (eo), an emissivity error (de) is
X1.3.5 It follows from the above that, in general terms, any introduced. The error in temperature measurement by an IR
noncontact IR thermometer must contain at least four essential thermometer as function of ambient and subject’s temperatures
components: an IR sensor to measure that net thermal radiation Ta and Tb (in Kelvin) respectively, may be expressed by the
flux Fb, a reference contact sensor to measure the temperature following equation:
Ts, an optical component to define the optical coefficient A, and
the computational means to calculate the subject’s temperature de 5 Tb – Œ
4 eo 4 4 4
eb ~ T b – T a ! 1 T a (X1.3)
Tb (Fig. X1.2). X1.3.6.5 The equation suggests that emissivity error grows
X1.3.5.1 In practice, the essential elements of the measure- smaller when ambient temperature approaches that of a subject
ment system may have many configurations and additions to or when emissivity of a blackbody matches that of the subject.
enhance accuracy and add features required for use of the Errors calculated for the object temperature of 37 °C are
device. These may include the IR flux choppers or shutters, illustrated in Fig. X1.3. When eb< eo, the IR thermometer
protective probe covers, reference targets, etc. Regardless of reading will be too low and will need to be readjusted upward
any practical implementation, the ultimate technical goal of the according to Eq X1.3 and Fig. X1.3 before accuracy can be
instrument is an accurate assessment of the subject’s surface adequately assessed. Conversely, when eb >eo, the IR ther-
temperature Tb. mometer readings will be too high and will need to be
X1.3.6 Emissivity: readjusted downwards.
X1.3.6.1 Emissivity is an indicator of how well an object X1.3.6.6 Example—An IR thermometer previously cali-
emits electromagnetic radiation from its surface. It is expressed brated with blackbody having emissivity of eo50.995 (as
using a dimensionless scale which ranges from 0 to 1.0. An measured in comparison with the standard blackbody described
ideal “blackbody” has an emissivity of 1.0 and, by definition, in Annex A1) is used at ambient temperature of ta525 °C to
is a perfect emitter. In reality, objects are never this efficient. measure temperature of a blackbody set at tBB537 °C and
Therefore, ideal blackbodies are modeled with practical black- having emissivity of eb50.985 (emissivity ratio eo/eb51.01).
bodies which have emissivities approaching unity as closely as The IR thermometer displayed temperature of 36.8 °C. Accord-
possible. ing to Eq X1.3 and Fig. X1.3, the reading shall be corrected for
X1.3.6.2 A cavity-type blackbody is commonly used to the emissivity error of –0.11 °C by subtracting that number
calibrate and verify the accuracy of IR thermometers. Due to from the displayed temperature. That is, the corrected reading
multiple internal reflections of infrared photons inside the
cavity, those which emerge through the cavity opening have IR
flux characteristics very near that which would emanate from
an ideal blackbody surface (1). Thus, the opening in the cavity
is considered a blackbody surface, though such a surface does
not exist in reality.
X1.3.6.3 Some practical “blackbodies” may have lower
emissivities than that of the recommended blackbody of Annex
A1 (often, they are called “graybodies”). In such cases,
9
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
Contact¬ASTM¬International¬(www.astm.org)¬for¬the¬latest¬information.¬
E 1965
shall be 36.8 (–0.11) 5 36.91 °C. After rounding for 0.1°
resolution, the corrected value of reading is 36.9 °C which
indicates that the IR thermometer under test reads blackbody
temperature lower by 0.1°, not by 0.2 °C as it would appear
from the uncorrected display.
X1.4 Medical Background—The ultimate medical goal of a
body temperature measurement is the accurate determination
of core body temperature. This is temperature close to that of
the blood in the body’s vital organs, such as the brain and heart.
As the next best thing to the core temperature measurement,
temperatures may taken from a body interior or body cavity
which represents core temperature with acceptable accuracy.
X1.4.1 Measurement Sites:
X1.4.1.1 Medical infrared thermometry has two distinct
types of measurements: body temperature measurement and
skin surface temperature measurement.
X1.4.1.2 Skin temperature measurements have specific ap-
plications in determining surface temperature of a human body. NOTE 1—Numbers exemplify temperatures on the surface of the ear
That temperature greatly depends on both the skin blood canal walls. Tympanic temperature tty5 37.3 °C. The average of all
perfusion and environmental conditions. Therefore, skin tem- temperatures over the ear canal surface within the field of view represents
perature can not be independently correlated with the internal temperature of the ear canal tec.
body temperature. FIG. X1.4 Ear Canal Within a Field View of an Ear Thermometer
X1.4.1.3 Body temperatures traditionally have been mea-
sured by contact thermometers in the oral, rectal, or axillary mating the core (tty;tc) on the surface of the tympanic
sites. These sites, however, were choices of convenience, rather membrane.
than of correctness. They often do not represent core body X1.4.2 Reference Sites:
temperature with required fidelity. Thus, during surgical pro- X1.4.2.1 In contrast to industrial types of infrared thermom-
cedures and in intensive care units, temperatures frequently are eters whose performance can be fully evaluated with a stan-
measured in the pulmonary artery (PA), distal esophagus, dardized thermal radiation source (a blackbody), accuracy of a
urinary bladder, or on the tympanic membrane, that are medical infrared noncontact thermometer should, in addition,
recognized core temperature sites. be assessed under real conditions involving temperature mea-
X1.4.1.4 Due to physiological and practical limitations, surements of patients. This demands use of a reference contact
only the auditory (ear) canal, including the tympanic mem- temperature probe placed inside the patient’s body. Preferably,
brane is suitable for routine noncontact infrared (IR) detection. such a reference probe should be placed into a body site that
The auditory canal is a nearly ideal cavity for IR body has a recognized core or near-core body temperature, such as
temperature measurement. It is not affected by respiration, the pulmonary artery, distal esophagus, urinary bladder, or
eating, drinking, or smoking. Anatomically, the canal is a tympanic membrane. Alternatively, reference temperatures
slightly curved tube about 3.5 cm (1.4 in.) long in an adult. It may be obtained from such traditional temperature measure-
is limited inside by the tympanic membrane. The canal is ment sites as oral cavity or rectum.
well-insulated from the exterior and is located in close prox- X1.4.2.2 Core body temperature is generally considered to
imity to major brain arteries and veins. It ends only about 3.5 be the temperature of the blood in the heart and the brain (11).
cm (1.4 in.) from the hypothalamus, which is the body thermal However, “core” is more a concept than a practical body site.
regulation center. In the same patient, temperatures measured from different
X1.4.1.5 Tympanic temperature is a recognized measure of “core” areas may vary noticeably. Probably the temperature of
core temperature (4,5,6) and the tympanic membrane is con- the blood perfusing the pre-optic region of the hypothalamus
sidered a temperature core site. Ear canal temperature as should be considered the body’s ultimate core temperature.
measured by an IR thermometer is relatively close to that of the Unfortunately, the hypothalamus is not easily accessible for
tympanic membrane and is not significantly influenced by local temperature measurement. Hence, pulmonary artery, distal
inflammations (the observed effect of otitis media was an esophageal, urinary bladder, tympanic, or even rectal tempera-
increase of about 0.1° (7) or a moderate amount of ear wax (the tures7 are often used for a thermal definition of core, with
observed effect when cerumen occludes the ear canal was pulmonary artery temperature considered the “gold standard”
between 0.1 and 0.3 °C (8,9). The interior portion of the ear (11).
canal quickly reflects dynamic changes in core temperature. X1.4.2.3 To obtain a core temperature, insertion of an
X1.4.1.6 It should be recognized, however, that tympanic invasive catheter is required. Often, this may not be justified
temperature (tty) is somewhat different than average ear canal
temperature (tec). Temperature inside the ear canal generally is
not uniform (Fig. X1.4) and may vary substantially from the 7
At least in adults, rectal temperatures may lag behind the rapid changes in core
near ambient on the surface of the auricle to a value approxi- temperature (10).
10
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
Contact¬ASTM¬International¬(www.astm.org)¬for¬the¬latest¬information.¬
E 1965
11
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E 1965
IR thermometer but also may depend on the size of a patient were measured by contact probes placed into the selected body
(16,17) and other factors. For this reason, the instrumentational sites.
offset should be verified separately for different age groups. X1.4.3.12 The combined site offsets could be added to the
X1.4.3.6 The instrumentational offset is defined as: unadjusted ear canal temperature tec of a subject to display, the
µd 5 t̄c –t̄ec (X1.6) estimated body site temperatures tb, such as oral or rectal.
X1.4.3.13 Fig. X1.7 shows the relationship between the
where: t̄ec is the average ear canal temperature of the selected
physiological, instrumentational, and combined site offsets,
group of subjects.
where the reference temperature is the core temperature tc. In
X1.4.3.7 Because the instrumentational offset depends on
most cases, unadjusted temperature tec of the ear canal, as
IR thermometer design and, therefore, is model-specific, each
measured by an IR thermometer, is lower than that of the core
manufacturer should establish the specific instrumentational
tc. In the diagram, arrows point toward warmer sites.
offset for its IR thermometer and, if required, make it selectable
for different age groups. X1.4.3.14 Core temperature can be estimated and displayed
X1.4.3.8 The instrumentational offset to some extent may by an IR thermometer by adding the instrumentational offset to
be controlled by a proper design. the ear canal temperature reading. The noncore body sites, such
X1.4.3.9 Combined Site Offset—When measuring tempera- as oral, rectal, or axillary, would require use of the combined
ture by an IR thermometer one usually deals with two site offsets.
offsets—physiological and instrumentational, where the former X1.4.3.15 Determination of the internal body temperature is
relates to the subject of measurement and the latter to the the ultimate goal of medical thermometry, in displaying the
instrument and its interface with the subject. temperature. Therefore, the IR thermometer manufacturers
X1.4.3.10 The combined site offset can be defined as a should use the appropriate offsets specific for particular IR
combination of the instrumentational and physiological offsets, thermometers and patient age groups, and should refrain from
or the difference between the average temperatures of a body displaying unadjusted ear canal temperature.
site t̄b and the ear canal t̄ec: X1.4.3.16 For example, under normal conditions, an ear
µs 5 µd – µp 5 t̄b – t̄ec (X1.7)
canal type IR thermometer outputs temperature that is adjusted
to oral temperature tbm. The displayed temperature tbm can be
X1.4.3.11 It should be clearly recognized that value of t̄ec is calculated from Eq X1.7 modified for the individual measure-
a temperature of the ear canal averaged (integrated) over both ment:
its surface area within the IR thermometer field of view (Fig.
tbm 5 tec 1 µsm (X1.8)
X1.4) and over the selected population of subjects. Unadjusted
ear canal temperature t̄ec is measured by a noncontact IR X1.4.3.17 Any ear canal type IR thermometer that is not
thermometer. Contrary, the value of t̄b represents the tempera- capable of measuring and displaying true tympanic tempera-
ture averaged over a group of subjects whose temperatures ture, tty, should not be called a “tympanic thermometer.” A
FIG. X1.7 Combined Site Offset is a Scalar Difference Between Instrumentational and Physiological Offsets
12
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
Contact¬ASTM¬International¬(www.astm.org)¬for¬the¬latest¬information.¬
E 1965
more appropriate name is an “infrared ear thermometer.” imperative to protect the instrument from becoming a carrier of
X1.4.3.18 Skin Temperature Measurement—Skin tempera- soiling compounds and a transmitter of infection from one
ture measurement technically is similar to that from the ear patient to another (cross-contamination) or even from re-
canal, but with two significant differences. The first is that the infecting the same patient (recontamination). Thus, any part of
skin emissivity may vary from site to site in the range from a thermometer that may come into contact with patient tissues
0.94 to 0.99 (18), while emissivity of an auditory canal may be shall be either protected by a cover or easily cleanable. Any
considered equal to unity (14). The other difference is the field disposable or reusable protective cover placed over the optical
of view, that in some thermometers may be quite wide. To probe becomes an attenuator of the net infrared signal and,
prevent spurious readings, the instrument design should ensure therefore, may alter the temperature reading. In effect, the
that infrared radiation is collected from a limited specified area probe cover becomes a part of the measurement system (see
of the skin surface, avoiding any stray thermal radiation from Fig. X1.2). This demands that covers be produced with
neighboring tissues and objects having different surface tem- tolerances that allow meeting these specifications by an entire
peratures. Thus, contrary to an IR ear thermometer, an IR system, which includes both the IR thermometer and the probe
thermometer for skin measurements should have means to cover. Evaluation of an IR thermometer accuracy always shall
compensate for skin emissivity and for defining the area of be made with a probe cover in place (if applicable). A new
measurement. probe cover shall be used for each temperature measurement
X1.4.3.19 Probe Covers—Because a medical IR thermom- with devices whenever such covers are labeled or implied as
eter is used in direct contact with patient tissues, it is disposable.
E 1965
such measurements shall be performed at each of five condi- closeness between the measured temperature and that of the
tions of ambient temperature and humidity (see Table 1). Thus, reference body site for a specified age group of patients. It is a
at each blackbody temperature setting, at least 30 errors must measure of the validity of the instrumentational or combined
be obtained for all combinations of operating temperature and offsets, or both, built into the IR thermometer. The value of
humidity. clinical bias should be accompanied by a statement of uncer-
tainty, which has a meaning of one standard deviation and
NOTE X2.1—Each environmental condition may require use of a
specific combined site offset µsm, if so specified by the manufacturer. generally is calculated as root-sum-of-squares (RSS) of stan-
dard deviation of data and other uncertainty components.
X2.2.3.4 The highest value of dj from the error set shall be Acceptable methods of evaluation of uncertainty are described
selected and used as a measure of laboratory error at that elsewhere (21,22).
particular blackbody setting.
X2.3.2.4 To evaluate clinical bias, at least two measure-
X2.2.3.5 In this example, for a blackbody setting near 37
ments should be taken from each subject in a test group. One
°C, a total of 30 measurements have been made at all five
reading should be taken from an ear canal by an IR ear
required combinations of operating temperatures and humidi-
thermometer under test, and the other should be taken by a
ties and the highest value of an error was found djmax 5
reference contact thermometer.
?–0.17? °C50.17 °C. Therefore, the IR thermometer under test
X2.3.2.5 To determine clinical bias ( x̄d), a mean value of
meets part of the requirement of 5.3 since that paragraph
ear-to-reference differences for all subjects in the test group
specifies that for a blackbody in the range of 37 °C, the highest
should be calculated.
permissible error shall be no more than 0.2 °C. The test shall
be performed for two other blackbody settings: near 35 °C and X2.3.3 Clinical Repeatability:
near 41 °C, at which the highest permissible error is 0.3 °C. X2.3.3.1 Clinical repeatability shows how consistently an
Therefore, a total of at least 90 measurements with an IR ear canal IR thermometer measures temperature from the same
thermometer shall be performed to evaluate its compliance patient when used by the same operator. The repeatability test
with the requirements for the laboratory error. requires taking several readings from the same patient under
the same conditions and comparing these readings with each
NOTE X2.2—Numbers in the example are provided for the purpose of other. This standard requires that three readings are taken. A
illustration only and do not represent any particular IR thermometer.
reasonable pause between measurements may be required
X2.3 Clinical Accuracy: because placement of the IR probe into an ear canal may affect
the ear canal surface temperature. A low thermal conductivity
X2.3.1 Clinical Accuracy Explanations:
of skin prevents a fast surface rewarming. A too short interval
X2.3.1.1 This specification recommends that a manufac-
between the measurements may compromise the measured
turer determines two kinds of errors that represent clinical
value of clinical repeatability. The highest possible rate of
accuracy: clinical bias with stated uncertainty, and clinical
taking temperatures from an ear canal should be recommended
repeatability. These characteristics may be evaluated from the
by the manufacturer.
same data set: multiple measurements of ear temperatures and
actual reference temperature on a selected number of febrile X2.3.3.2 It is recognized that small variations in ear canal
and afebrile subjects in all applicable age groups. Use of power temperature may occur naturally during the time of the test.
analysis and random sampling are recommended to ensure that These variations should be considered as part of clinical
the number of subjects in each group is sufficiently large to repeatability.
minimize the effects of random components of the measure- X2.3.3.3 For the purpose of determining clinical repeatabil-
ment error. For example, paragraph 19.3 on Bias in Practice ity, three sequential IR readings should be taken in the same ear
E 177 recommends 30 or more test subjects. of each subject by the same operator. to determine clinical
X2.3.1.2 As a guideline, this specification recommends repeatability sr, three temperature deviations Dij for each
division of all subjects into three age groups, namely: (1) subject should be calculated:
infants—newborn to one year; (2) children—greater than one D1j 5 te2j – te1j (X2.2)
to five years; and (3) adults—greater than five years old. D2j 5 te3j – te2j
X2.3.2 Clinical Bias and its Uncertainty: D3j 5 te1j – te3j
X2.3.2.1 Clinical bias ( x̄d) specifies an average (mean)
difference between temperatures as measured by the ear canal where: te1j, te2j, and te3j are the first, second, and third IR
IR thermometer under test operating in all adjusted modes and temperature readings from the same ear canal of a subject
temperatures of subjects, from a selected group, as measured numbered j.
by contact thermometers positioned in a selected body refer- X2.3.3.4 The following formula should be used to calculate
ence site. Clinical bias is the systematic distortion of a the pooled standard deviation sr of all Dij for all N tested
statistical result (20). subjects:
Œ
X2.3.2.2 It should be clearly understood that clinical bias is N
a mean value of a set of individual clinical biases obtained ( ~D1j2 1 D2j2 1 D3j2
i51
from a representative group of patients. As opposed to labora- sr 5 6N (X2.3)
tory error that is a maximum deviation of readings, clinical bias
is an average value of individual errors. where the value of sr is the measure of clinical repeatability.
X2.3.2.3 The clinical bias for each display mode defines X2.3.3.5 Three readings from the same ear are required to
14
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
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E 1965
calculate three temperature deviations Dij. Since the total reference by more than 1 °C may exist (23). This may be
number of subjects in a group is N the entire data set includes caused by physiological factors, such as lagging of the rectal
n 5 3N measurements. These numbers represent consistency reference site (if that site is used as a reference) behind the true
of multiple readings with respect to one another, regardless of core temperature, rather than inaccuracies in the IR thermom-
the actual temperatures of subjects or the display mode of the eter. Other studies also exist that question the accuracy of IR
IR thermometer. The measure of the clinical repeatability is the thermometers of various brands (24, 25).
pooled standard deviation of these n numbers. X2.3.4.6 Example for Clinical Bias—An IR thermometer
X2.3.4 Example of Tests for Clinical Accuracy: was tested with subjects of various ages. The operating mode
X2.3.4.1 Two types of thermometers are used in the tests: an was labeled by a manufacturer as adjusted to core temperature,
IR thermometer (the device under test) and a contact reference The manufacturer specified in the instruction manual that its IR
thermometer of electronic type adapted for measuring tempera- thermometer can be used on all subjects regardless of age.
ture from a selected reference site—pulmonary artery, distal X2.3.4.7 For the purpose of evaluation of clinical bias, all
esophagus, urinary bladder, or tympanic membrane for core, or subjects were divided into three age groups: from zero to one
rectal and oral thermometers for the non-core body sites. year of age (infants), older than one to five (children), and older
X2.3.4.2 The method of taking temperatures with both IR than five (adults).
and reference thermometers shall be in full compliance with X2.3.4.8 Subjects with certain characteristics were excluded
the recommendation of their respective manufacturers. from the test: external ear inflammation, auditory canal ob-
X2.3.4.3 Before or after the tests, laboratory accuracy of the struction (anatomic or foreign material), use of medications
reference thermometer should be verified in a stirred water known to affect body temperature (for example, antipyretics,
bath. The water bath should have a volume of 1 L (1 qt) or barbiturates, thyroid preparations, antipsychotics, etc.) within 3
greater and temperature stability within 6 0.02 °C (6 0.04 °F). h of the test, or immunization within seven days of the test.
True temperature of water should be monitored with an X2.3.4.9 The test was performed at ambient temperatures
uncertainty no greater than 6 0.03 °C (6 0.05 °F) by an within the range of 20 to 28 °C (68 to 82 °F) and the relative
immersed contact thermometer with calibration traceable to a humidity from 40 to 70 %. Reference temperatures were taken
national physical standard of temperature. Laboratory accuracy by a contact tympanic probe positioned on the left tympanum
of an IR thermometer under test should be verified in a of an anesthetized subject. The IR reading were taken of the
water-immersed blackbody (see Annex A1) or in the manufac- right ear canal by the IR ear thermometer under test. Within
turer recommended blackbody if such a blackbody was used each age group both afebrile and febrile subjects (tympanic
for the device calibration. During data processing, the clinical temperature of 38 °C or higher) were represented by nearly
data should be corrected for calibration inaccuracy, if any, of equal numbers (see Table X2.1).
the IR or reference thermometers, or both.
X2.3.4.10 Uncertainty of bias was estimated as RSS of a
X2.3.4.4 The tests should be performed separately on the
standard deviation of IR measurements and anticipated uncer-
age groups of subjects that are considered as prospective
tainties in calibration of the reference and IR thermometers.
subjects whose temperature would be measured by the IR ear
Evaluation of x̄d for Group I indicates that clinical bias is equal
thermometer. Sufficient number of both febrile and afebrile
to –0.25 °C with uncertainty of 6 0.35 °C which is indicative
subjects should be tested.
of a wide range for difference between the IR thermometer
NOTE X2.3—For the purpose of these tests, fever is defined as core reading and reference temperature. Although this specification
temperature of 38.0 °C (100.4 °F) or higher. does not set limits for clinical bias, the wide uncertainty range
X2.3.4.5 It should be noted that values characterizing clini- for the bias appears excessively large, indicating that the IR
cal accuracy are functions of both the IR and reference thermometer under test may not be sufficiently accurate for use
temperatures and may be significantly affected by stability of on infants since errors in temperature measurements may be
the reference temperature measurement. Clinical studies have clinically significant. Therefore, the instrument should be
shown that although the mean offset or clinical bias may be appropriately labeled to restrict its use with such subjects.
correct for a given thermometer, readings which differ from the X2.3.4.11 Clinical biases and uncertainties for Groups II
TABLE X2.1 Examples of Comparative Temperature Measurements by IR (te1) and Reference (tcj) Thermometers of Subjects of Three
Age Groups
15
NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
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E 1965
and III are sufficiently small which is an indication that the IR X2.3.4.13 The corresponding temperature deviations are
thermometer under test can be used reliably with these age calculated according to Eq X2.3.
groups. D1j 5 38.5–38.7 5 –0.2
NOTE X2.4—Numbers in the example are provided for the purpose of D2j 5 38.6–38.5 5 0.1
illustration only and do not represent any particular IR thermometer. D3j 5 38.7–38.6 5 0.1
X2.3.4.12 Example for Clinical Repeatability—In Group II Errors from all N531 subjects of the test group were used in
(of example X2.3.4.2), three ear canal temperatures taken from the calculation of clinical repeatability according to Eq X2.3
a subject number j by an ear type IR thermometer resulted in and produced value of sr50.15, that may be considered
the following readings: reasonably small and not to pose a problem for diagnostic
te1j 5 38.7 °C, te2j 5 38.5 °C, te3j 5 38.6 °C purposes.
REFERENCES
(1) Fraden, J., Handbook of Modern Sensors: Physics, Design and (15) Fraden, J., and Lackey, R. P., “Estimation of Body Sites Temperatures
Applications, 2nd Ed, American Institute of Physics, New York, 1997. from Tympanic Measurements,” Clin. Pediatrics, 30, Supplement,
(2) Richmond, J. C., and DeWitt, D. P., Eds, “Applications of Radiation 1991, pp. 65–70.
Thermometry,” ASTM Special Technical Publication, Philadelphia, (16) Erickson, R. S., and Woo, T. M., “Accuracy of Infrared Ear
1985.
Thermometry and Traditional Temperature Methods in Young Chil-
(3) Fowler, J. B., “A Third Generation Water Bath Based Blackbody
dren,” Heart & Lung, 23, 1994, pp. 181–195.
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